Germany orders recall of some Novartis flu shots

October 25, 2012 by Frank Jordans
This Oct. 25, 2011 file photo shows the logo of Swiss pharmaceutical company Novartis AG on one of their buildings in Basel, Switzerland. Novartis AG on Thursday, Oct. 25, 2012, reported a net profit of $2.48 billion during the third quarter, with income remaining flat as new drugs offset patent expirations. The Basel-based company's profits between July and September were virtually unchanged from $2.49 billion in the third quarter of 2011. (AP Photo/Keystone, Georgios Kefalas, File).

(AP)—German authorities ordered a recall Thursday of some batches of Novartis flu vaccine as a precautionary measure after the company reported the appearance of small particles in the manufacturing process.

The Paul Ehrlich Institute, which is part of the country's Ministry of Health, said there had been no reports of particle formation in Germany or of any serious side effects during the current flu season.

"However, in the interest of risk prevention and consumer safety it is necessary to cancel the approval for certain vaccines, since the formation of particles in the vaccine and therefore the risk of serious side effects cannot be ruled out," Institute President Prof. Klaus Cichutek said in a statement.

The decision affects four batches of the influenza vaccine Begripal and one batch of Fluad. It does not affect the seasonal vaccine Optaflu.

Italy's health ministry banned the sale of four Novartis flu drugs on Wednesday. These included Fluad and Begripal—sold as Aggripal in Italy—as well as two others: Influpozzi Adiuvato and Influpozzi Subunita.

Switzerland's regulator Swissmedic also suspended deliveries of flu vaccines from Novartis as a preventive measure.

Britain's Medicines and Healthcare products Regulatory Agency said there was no evidence yet to pull the vaccines off the market but added it was gathering further information on the Novartis vaccines.

The Swiss pharmaceutical company said Thursday it was cooperating with the Ministry of Health in Italy, where the vaccines are produced, and was committed to providing vaccines to patients for the current flu season. There had been no adverse effects reported so far from more than 1 million doses of Agrippal/Begripal and Fluad administered, the Basel-based company said.

"Novartis confirms that these particles can occur in the vaccine manufacturing process and is confident that there is no impact on the safety or efficacy of the vaccine," it said in a statement.

Explore further: Italy, Switzerland, Austria freeze sales of Novartis flu vaccines

shares

Related Stories

Italy, Switzerland, Austria freeze sales of Novartis flu vaccines

October 24, 2012
Italian, Swiss and Austrian authorities on Wednesday halted the sale of flu vaccines made by Swiss pharmaceutical giant Novartis.

Novartis insists its flu vaccines are safe

October 25, 2012
Swiss pharmaceutical giant Novartis insisted early Thursday that its flu vaccines were safe despite a sales ban by Italy, Switzerland and Austria.

New development could increase flu vaccine supply

June 2, 2011
(Medical Xpress) -- Scientists from the U.S. Food and Drug Administration and the pharmaceutical company Novartis announced today in the journal Science Translational Medicine that they have developed a new adjuvant, or compound ...

Recommended for you

Drug for spinal muscular atrophy prompts ethical dilemmas, bioethicists say

December 11, 2017
When the Food and Drug Administration approved the first drug for people with spinal muscular atrophy a year ago, clinicians finally had hope for improving the lives of patients with the rare debilitating muscular disease. ...

FDA's program to speed up drug approval shaved nearly a year off the process

December 7, 2017
Speeding the pace at which potentially lifesaving drugs are brought to market was a rallying cry for Donald Trump as a candidate, and is a stated priority of his Food and Drug Administration commissioner, Dr. Scott Gottlieb. ...

Dangers of commonly prescribed painkillers highlighted in study

December 6, 2017
Commonly prescribed painkillers need to be given for shorter periods of time to reduce the risk of obesity and sleep deprivation, a new study has revealed.

Viagra goes generic: Pfizer to launch own little white pill

December 6, 2017
The little blue pill that's helped millions of men in the bedroom is turning white. Drugmaker Pfizer is launching its own cheaper generic version of Viagra rather than lose most sales when the impotence pill gets its first ...

Surgery-related opioid doses can drop dramatically without affecting patients' pain

December 6, 2017
Some surgeons might be able to prescribe a third of opioid painkiller pills that they currently give patients, and not affect their level of post-surgery pain control, a new study suggests.

Four-fold jump in deaths in opioid-driven hospitalizations

December 4, 2017
People who end up in the hospital due to an opioid-related condition are four times more likely to die now than they were in 2000, according to research led by Harvard Medical School and published in the December issue of ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.